The FDA, a federal agency responsible for food and drug control, approved the first dengue vaccine, Danwaxia, but has established significant restrictions on its use once it has been proven that immunization has left some people at greater risk of contracting a more severe form of the disease.
With the release of the vaccine, the agency recognizes the key public health benefit of a disease that affects hundreds of millions of people around the world. The decision can also help the product that is struggling because its use is impaired due to concerns about possible risks.
"It shows the world that, if used properly, the vaccine can be effective," says Duane Gubler, a professor of medicine at Duke-NUS Medical School, one of the developers of a dengue-based vaccine produced by Takeda. a former consultant for Sanofi, responsible for Denguctionia.
Sanofi is selling Denguccia to other countries in 2015, but the vaccine suffered a major decline in 2017, after the Philippine government, which massively distributed the product among school-age children, suspended the application and withdrawn Sanofi's license. The decision was made after the pharmaceutical giant announced that in rare cases, people who have never been affected by dengue may develop a much more severe form of the disease if they were infected with the virus after immunization.
Last week, the FDA restricted vaccine approval for people aged 9 to 16 living in areas where dengue is endemic and proven to be contaminated by the disease.
According to US Centers for Disease Control and Prevention (CDC), more than a third of the world's population lives in areas where there is a risk of infection with a mosquito-borne dengue virus.
This disease can be triggered and cause high fever, headache, muscle and joint pain, and persistent weakness. After infecting for the second time, the individual may develop a more severe form of the disease, which can cause hemorrhage or shock and be fatal.
It is estimated that 400 million viral infections occur worldwide and 500,000 cases of severe form, dengue haemorrhagic, responsible for the death of about 20,000 people, according to the CDC. There are no approved drugs for the treatment of dengue.
According to CDC data, most dengue cases in 48 neighboring states in the United States were hired outside the country by travelers or immigrants, although there are isolated epidemics, such as in southern Texas in 2005. The dengue is endemic in the territories of Americans from American Samoa, Guam, Puerto Rico and the Virgin Islands.
"I believe the message is to recognize the severity of the disease and the need to do something about it," said Vincent Rakaniello, a professor of microbiology and immunology at Columbia University. He fears that recognizable vaccine risks can deepen skepticism-unreasonable – about vaccines in general, who is now responsible for the global occurrence of measles. "This will give them more ammunition, they can use it to say," Well, we have launched a vaccine that is known to have problems, "he argues.
In the Philippines, immunization against measles in children has dropped dramatically as a result of the protests against Denkaxia, which contributed to a country's epidemic, which resulted in another 400 deaths since January, according to a report released by UNICEF and the World Health Organization last week.
Although today Dengvaxia is the only form of immunization of dengue that is available on the market, other vaccines are developed and are believed to be more effective and can be applied to people who have never been infected with the dengue virus. Among them is Takeda, already in the final phase of the clinical trials, and others that Merck plans to present on the market. "A very broad plan of action is being formulated to treat dengue," said Rakanie.
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